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Trazodone for Obstructive Sleep Apnea

Phase 1 & 2

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate-to-severe OSA (AHI ≥ 15 events/hr)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 night

Awards & highlights

Study Summary

This trial aims to test if giving trazodone before sleep can help improve symptoms and severity of obstructive sleep apnea by allowing the upper airway muscles to work effectively during sleep.

Who is the study for?

This trial is for individuals with Obstructive Sleep Apnea (OSA), particularly those who wake up too early during an obstructive event, preventing their airway muscles from responding properly. Specific eligibility criteria are not provided.Check my eligibility

What is being tested?

The study tests the effect of Trazodone Hydrochloride, a medication given before sleep, on OSA severity and traits compared to a placebo. The goal is to see if Trazodone can improve sleep quality in OSA patients.See study design

What are the potential side effects?

While specific side effects for this trial aren't listed, common side effects of Trazodone may include drowsiness, dizziness, constipation, blurred vision, and dry mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have moderate-to-severe sleep apnea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 night

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 night

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 night for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of trazodone on arousal threshold (%eupnea)

Secondary outcome measures

Effect of trazodone on apnea hypopnea index (events/h)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TrazodoneExperimental Treatment1 Intervention

Trazodone capsule 30 min before sleep

Group II: PlaceboPlacebo Group1 Intervention

Placebo capsule 30 min before sleep

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,932 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than 60 years old being sought for enrollment in this study?

"To be eligible for participation, individuals must be between 21 and 70 years old according to the entry criteria of this research."

Answered by AI

What is the upper limit on the number of participants involved in this clinical investigation?

"Indeed, the details on clinicaltrials.gov affirm that recruitment is ongoing for this particular trial. The trial was publicly listed on January 1st, 2024 and underwent its latest update on February 22nd of the same year. Participation opportunities are available for a total of 18 individuals at a single designated site."

Answered by AI

Who meets the criteria to participate in this medical study?

"Individuals eligible for this trial must be diagnosed with obstructive sleep apnea and fall within the age range of 21 to 70. A total of 18 participants are sought for inclusion in the study."

Answered by AI

Are individuals still eligible to apply for participation in this ongoing trial?

"Per information from clinicaltrials.gov, this research trial is presently enrolling participants. The study was originally listed on 1st January 2024 and last revised on 22nd February 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trazodone on OSA Endotypes

Ludovico Messineo 2024. "Trazodone on OSA Endotypes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06286189.

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